by
Lisa Chamoff, Contributing Reporter | May 12, 2014
From the May 2014 issue of HealthCare Business News magazine
Richard Lazar of Readiness Systems, which helps organizations design, implement and operate AED programs, says this self testing gives AED owners the opportunity to have the devices serviced before they’re needed in sudden cardiac arrest emergencies.
“Those devices are sometimes recalled, sometimes fixed, but those activities occur, by and large, before point of use,” Lazar says. In comments to the FDA on the reclassification, Lazar noted that despite many AED recalls over the years, the devices work as expected during rescue attempts more than 99.5 percent of the time and that the point-of use failure rate falls between .19 and .49 percent.
Lazar says he doesn’t think the FDA understands public access defibrillation.
“It is perhaps the most unique medical device in a sense that it’s designed to be put in the hands of laypeople and the FDA doesn’t know what to do with that,” Lazar says. “This is a people problem, not a device problem.”
In a media call discussing the proposed order last March, Dr. William Maisel, deputy director of the FDA’s Center for Devices and Radiological Health, acknowledged that the devices “serve a very important public health need,” but said that the reclassification is aimed at helping AED manufacturers improve the quality and reliability of the devices, with problems stemming from the performance of components purchased from suppliers used to manufacture the AEDs.
Maisel noted that from 2005 to 2012, the FDA received approximately 45,000 reports of malfunctions in adverse events associated with AEDs and that there were 88 recalls. He admitted that it’s difficult to conclusively determine how many deaths resulted from these malfunctions because “many patients die even when the devices worked perfectly well.”
Maisel said the PMA process “provides additional manufacturing controls that we cannot get through the 510(k) process. Specifically, it allows us to review the quality systems, including design and manufacturing processes that are part of the manufacture of these products.”
Last year, an informal group of AED manufacturers called on a consultant and accredited biostatistician, Dr. Wayne Taylor, to analyze the Medical Device Reports (MDRs) for AEDs over a period of five years to see if there were any trends. Taylor included this analysis in comments to the FDA about the proposed order under the auspices of a group called the Alliance of External Defibrillator Manufacturers.
Taylor collected and analyzed Medical Device Reports from AEDs used by both laypeople and professionals, such as EMS workers, and compared the number of reports to the number of devices in use. The analysis found that the rate of MDRs, which included adverse events, was not trending upward, and that in two of the seven cases analyzed, there was an indication of a downward trend.
